NCT01106742

Brief Summary

Based on the anti-inflammatory and stabilising effect of the AbM, (Agaricus Blazei Murill) based mushroom extract AndoSanTM on cytokine release in blood in vivo and ex vivo in healthy volunteers after 12 days consumption, the aim in this study is to investigate whether same effect is valid in patients with IBD (inflammatory bowel disease). In addition, calprotectin an abundant cytosolic protein in neutrophils and a surrogate marker for degree of intestinal inflammation will be measured in blood and feces of these patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2009

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

April 20, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 19, 2011

Status Verified

March 1, 2009

Enrollment Period

2.3 years

First QC Date

March 19, 2009

Last Update Submit

July 18, 2011

Conditions

Inflammatory Bowel Disease

Keywords

InflammatoryAbMIBD

Outcome Measures

Primary Outcomes (1)

  • The ultimate goal is to see whether the ABM can be used as additional treatment of IBD.

    12 days

Study Arms (2)

AndoSan, UC

EXPERIMENTAL

AndoSan as a supplement to 10 UC patents

Dietary Supplement: AndoSan

AndoSan, CD

EXPERIMENTAL

AndoSan as a supplement to 10 CD patients.

Dietary Supplement: AndoSan

Interventions

AndoSanDIETARY_SUPPLEMENT

AndoSan, 20mlx3, 12 days

Also known as: Agaricus blazei Murill
AndoSan, CDAndoSan, UC

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate disease activity

You may not qualify if:

  • No use of Imurel (Azathioprin) or anti-TNF treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Department of Surgery

Oslo, 0407, Norway

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

AndoSan

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 19, 2009

First Posted

April 20, 2010

Study Start

March 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 19, 2011

Record last verified: 2009-03

Locations

NO(1)